Tablet and method of preparing the same

Abstract

Disclosed is a method for preparing a tablet. The method can improve the compressibility of the active ingredients and produce tablets of uniform quality, bringing about the advantage of increasing tablet hardness with an increase in compression pressure, easily controlling disintegration time, and decreasing tablet friability by using the active ingredient fimasartan, a pharmaceutically acceptable salt thereof or a hydrate or solvate thereof having a specific particle size distribution.

What is claimed is: 
     
       1. A method for preparing a tablet, comprising:
 milling at least 50% (v/v) of an active ingredient based on the total amount of the active ingredient into particles which have a diameter of 10 μm or less, the active ingredient being fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof; 
 mixing the particles of the milled active ingredient with a pharmaceutically acceptable additive to give a mixture; and 
 forming the tablet from the mixture. 
 
     
     
       2. The method of  claim 1 , wherein the milling is carried out in such a way that 90% (v/v) of the active ingredient based on the total amount of the active ingredient contained in the tablet is milled into the particles having a diameter of 25 μm or less. 
     
     
       3. The method of  claim 1 , wherein the milling is carried out in such a way that 90% (v/v) of the active ingredient based on the total amount of the active ingredient contained in the tablet is milled into the particles having a diameter of 15 μm or less and 50% (v/v) of the active ingredient based on the total amount of the active ingredient contained in the tablet is milled into the particles having a diameter of 6 μm or less. 
     
     
       4. The method of  claim 1 , wherein the milling is carried out in such a way that the active ingredient contained in the tablet is milled into particles having a diameter of 0.5 μm or more. 
     
     
       5. The method of  claim 1 , wherein the milling is carried out in such a way that the active ingredient contained in the tablet is milled into particles having a diameter of 2 μm or more. 
     
     
       6. The method of  claim 1 , wherein the milling is carried out in such a way that the active ingredient contained in the tablet is milled into particles with a diameter of 3 μm or more. 
     
     
       7. The method of  claim 1 , wherein the forming the tablet comprises:
 preparing granules from the mixture; 
 adding an additional pharmaceutically acceptable additive to the granule to give a granule-containing mixture; and 
 compressing the granule-containing mixture into the tablet. 
 
     
     
       8. The method of  claim 7 , wherein the forming the tablet further comprises adding a binder to the mixture before the preparation of granules. 
     
     
       9. The method of  claim 1 , wherein forming the tablet comprises compressing the mixture into the tablet. 
     
     
       10. The method of  claim 1 , wherein the active ingredient is a hydrate of fimasartan potassium. 
     
     
       11. The method of  claim 1 , wherein the active ingredient is fimasartan potassium trihydrate. 
     
     
       12. The method of  claim 1 , wherein the pharmaceutically acceptable additive is selected from the group consisting of lactose or a hydrate thereof, microcrystalline cellulose, croscarmellose sodium, magnesium stearate and mixture thereof. 
     
     
       13. A tablet, comprising fimasartan, a pharmaceutically acceptable salt thereof, or a hydrate or solvate thereof as an active ingredient, and a pharmaceutically acceptable additive,
 wherein 50% (v/v) of the active ingredient based on the total amount of the active ingredient is a particle having a diameter of 10 μm or less. 
 
     
     
       14. The tablet of  claim 13 , wherein 90% (v/v) of the active ingredient based on total amount of the active ingredient is the particles having a diameter of 25 μm or less. 
     
     
       15. The tablet of  claim 13 , wherein 90% (v/v) of the active ingredient based on total amount of the active ingredient contained in the tablet is the particles having a diameter of 15 μm or less and 50% (v/v) of the active ingredient based on the total amount of the active ingredient is the particles having a diameter of 6 μm or less. 
     
     
       16. The tablet of  claim 13 , wherein the active ingredient comprises the particles having a diameter of 0.5 μm or more. 
     
     
       17. The tablet of  claim 13 , wherein the active ingredient comprises the particles having a diameter of 2 μm or more. 
     
     
       18. The tablet of  claim 13 , wherein the active ingredient comprises the particles having a diameter of 3 μm or more. 
     
     
       19. The tablet of  claim 13 , wherein the tablet is a coated tablet. 
     
     
       20. The tablet of  claim 13 , wherein the active ingredient is fimasartan potassium trihydrate.